Pharmaceutical order verification for an automated pharmacy system

ABSTRACT

A pharmaceutical order verification system and method for an automated pharmacy system is disclosed. A computerized line control application controls a dispensing line, facilitates automated dispensing of drugs into vials, and collects and records data for dispensed drug as well as each verification step performed by a pharmacist. In an example embodiment, pharmacist verification occurs in connection with replenishing the drugs in automated tablet counters and in connection with verifying a specified percentage of orders for each automated tablet counter. During the replenishment process, the pharmacist verifies that a replenishment canister has been loaded with the correct drug in the appropriate dosage and strength. During the order verification step, a pharmacist verifies the contents of vial matches the prescription order data. The line control application tracks the number of orders that are identified for pharmacist verification to ensure verification requirements are met for each automated tablet counter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to US Provisional Patent ApplicationNo. 61/862,921, titled PHARMACEUTICAL ORDER VERIFICATION FOR ANAUTOMATED PHARMACY SYSTEM and filed on Aug. 6, 2013, the contents ofwhich are incorporated herein by reference.

BACKGROUND

Many health benefit plan providers and retail pharmacies now offer theirclients the option of obtaining prescription drugs by mail. Mail orderpharmacies ship prescription drugs to a client's home so the client isnot required to visit a pharmacy and to fill a prescription in person.For clients with chronic conditions or other conditions that requiremaintenance drugs, a mail order prescription program is an attractivebenefit because it is more convenient for the clients and typically lessexpensive than obtaining prescription drugs at a neighborhood pharmacy.For many drugs, clients have the option of purchasing a drug fill in a60-day or even a 90-day supply at a lower cost than a 30-day supply.

Many mail order pharmacies use automated pharmacy systems and dispensinglines to process and ship a high volume of prescriptions on a dailybasis. Depending upon how the technology is implemented and deployedwithin a mail order pharmacy, a substantial number of steps in thefulfillment process may be automated and the need for human interventionminimized. Mail order pharmacies operated in the US, like theirneighborhood counterparts, must be licensed in a state and are subjectto numerous rules and regulations established by the licensing state'sboard of pharmacy. One common requirement is that a pharmacy, whether aneighborhood pharmacy or a mail order pharmacy, must meet pharmacistverification requirements for certain prescriptions. Verificationtypically involves reviewing medication orders and overseeing thepreparation and selection or packaging of medication doses according tothe order to verify the right medication is delivered to the rightpatient.

For automated pharmacy systems, pharmacist verification involves manualsteps that must be integrated into the automated fulfillment process. Ata minimum, the pharmacist must verify the appropriate drugs aredispensed in the vials that are shipped to a patient. Althoughpharmacist verification is required as part of the fulfillment process,pharmacist involvement is not required in all aspects of the fulfillmentprocess. In fact, pharmacist involvement in the fulfillment processbeyond verification requirements contributes substantial labor coststhat can reduce the cost-effectiveness of an automated pharmacy system.Therefore, there is a need for an automated pharmacy system withpharmaceutical order verification that meets verification requirementsin an efficient and cost effective manner.

SUMMARY

The present disclosure is directed to a pharmaceutical orderverification system and method for an automated pharmacy system. Thedisclosed pharmaceutical order verification system and methodincorporates pharmacist verification steps into automated processing oforders and maintains compliance with verification regulations from anoversight board such as a state Board of Pharmacy. A computerized linecontrol application that controls a dispensing line and facilitatesautomated dispensing of drugs collects and records data for eachverification step performed by a pharmacist. The computerized linecontrol application operates in conjunction with security and controlprocedures that minimize manual intervention in the fulfillment workflowthereby reducing the likelihood of introducing human errors.

In an example embodiment, pharmacist verification occurs at two pointsin the fulfillment process. During the fulfillment process, pharmacistverification occurs 1) in connection with replenishing the drug supplyin automated tablet counters; and 2) in connection with verifying aspecified percentage of orders for each automated tablet counter. Eachverification step is supported by computerized technology to collect andrecord data during the verification step. Security and control measuresin the fulfillment process minimize the opportunities for manualintervention following verification so that the possibility of humanerrors in dispensing the drugs is minimized.

During the replenishment process, the pharmacist verifies that areplenishment canister has been loaded with the correct drug in theappropriate dosage and strength. Additional controls ensure thereplenished canister is mounted on the appropriate automated pillcounter in the automated dispensing system. Following the replenishmentprocess, the process of dispensing drugs into vials for eachpharmaceutical order is fully automated. Each pharmacy order identifiesthe drugs that a specified patient should receive. Based on the drugsidentified in an order, vials are directed to the appropriate automatedtablet counter where they are filled with the quantity identified in theorder and then automatically sealed. Processing is fully automated untilfilled, sealed vials reach a packaging station where they areautomatically dropped into shipping envelopes. An operator adds printeddocumentation to each order envelope and seals the envelope for shippingto a patient.

During the order verification step, a pharmacist verifies the contentsof a vial matches the prescription order data. After each vial isfilled, an image of the vial contents is captured by an in-line camera.As the vial passes under the in-line camera, an image of the vialcontents is archived with the prescription order data. A pharmacistaccesses a pharmacist verification application to view vial images andverify the contents of a vial matches the prescription order data.Orders that pass the pharmacist's verification proceed to packagingstation while orders that do not pass the pharmacist's verification arererouted for exception. In an example embodiment, applicableverification regulations require pharmacist verification for a specifiedpercentage of orders for each automated tablet counter. A controlapplication tracks the number of orders that are identified forpharmacist verification to ensure the percentage requirements are metfor each automated tablet counter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an automated dispensing line schematic diagram according to anexample embodiment;

FIG. 2 is an ATC according to an example embodiment;

FIG. 3 is a replenishment canister for an ATC according to an exampleembodiment;

FIG. 4 is a flowchart for a secure replenishment software moduleaccording to an example embodiment;

FIG. 5 is a flowchart of a pharmacist verification software moduleaccording to an example embodiment.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENT(S)

Referring to FIG. 1, an automated dispensing line schematic diagramaccording to an example embodiment is shown. The line may comprise aplurality of conveyors 100 102 for transporting vials 108 110 112 toautomated tablet counters (ATC), sorting stations 104 106, and otherlocations on the line. In an example embodiment, each vial istransported in a puck that contains the vial and that comprises an RFIDtag for use in routing the vial on the line and dispensing a medicationfrom an ATC into the vial. A plurality of stations (ATCs, diverters,etc.) on the line comprise an RFID reader that reads the identifyinginformation for a puck/vial and transmits it to a line controlapplication that facilitates pharmaceutical order processing. The linecontrol application receives order data (e.g., drug identifying datasuch as a National Drug Code (NDC), dosage, and quantity) as well as anRFID identifier for a puck that contains a vial in which the drug willbe dispensed. Pucks are then routed by the line control application toappropriate stations (e.g., ATC with identified drug, sorting station,packaging station) so the drugs can be dispensed into the vials andshipped to patients. Vials are routed using the conveyors 100 102 andare diverted to various stations on the line or other conveyors usingmechanical diverting devices 114 116 118 120 that “push” a vial from onedirection of travel to another.

Referring to FIG. 2, an ATC according to an example embodiment is shown.In an example embodiment, an ATC is adapted to receive a canistercontaining the drug to be dispensed from the ATC. The canister is loadedat the top of the ATC 130 and the tablets or pills are dispensed throughan opening at the bottom of the ATC 132. Each canister comprises abarcode that identifies the ATC location and contents. The ATCs alsocomprise various sensors and other components to track the dispensing oftablets or pills from the ATC. Data related to the dispensing of drugsis collected at each ATC and communicated to the line controlapplication to facilitate the replenishment of ATCs when they becomeempty or nearly empty. While most of the fulfillment process isautomated, replenishment of ATCs involves several manual steps. Dataregarding the replenishment process is collected and recorded accordingto well-defined procedural controls, including pharmacist verification,to reduce the likelihood that the wrong drug is dispensed from an ATC.

Replenishment requests are processed through the line controlapplication and routed to pharmacy associates that are responsible forloading ATC canisters and staging them for pharmacist review andverification. When an ATC on the dispensing line needs to bereplenished, the replenishment request data (e.g., ATC identifier, ATClocation, NDC) is added to a queue of requests. The pharmacist associateopens the request at a workstation, reviews the request, obtains therequested drug and fills the canister, and updates the request toindicate the canister has been filled. The request status is updated toindicate the canister is ready for pharmacist verification.

Referring to FIG. 3, a replenishment canister for an ATC according to anexample embodiment is shown. A canister 140 is transparent to facilitateviewing of the canister contents. Each canister comprisesa bar code 142that is associated with a description of the canister and its contents(e.g., NDC and dose). For example, one canister may be used to dispenseCRESTOR® 10 mg tablets while another canister is used to dispenseCelebrex® 200 mg tablets. Once a canister has been filled, the associatelocks the canister with a cable tie 144 that also has a security tagbarcode.

Referring to FIG. 4, a flowchart for a secure replenishment softwaremodule according to an example embodiment is shown. Initially,identifying data such as barcodes for ATCs, canisters, and cable ties isentered in the module 200, 202, 204. A replenishment request comprisingATC identifying information is received at the module from the linecontrol application 206. After a pharmacy associate fills a canister,the associate scans the canister barcode, security tag barcode for acable tie used to secure the refilled canister, and ATC barcode andstages the canister for pharmacist review 208. The replenishment requestis updated with the scanned data to indicate the canister is ready forpharmacist verification. A notification is sent to a pharmacistverification software module that alerts a pharmacist of the need toverify the canister contents 210.

The pharmacist completes the review of the replenishment canister at apharmacist verification station. In an example embodiment, the requestdata is displayed for the pharmacist as well as an image of therequested drug. Once the pharmacist verifies the requested drug has beenadded to the canister, the replenishment request is updated with theverification data 212.

Following pharmacist verification, the canister is staged for loading onthe ATC associated with the request. A pharmacy associate takes thecanister to the ATC on the dispensing line, scans the canister barcode,loads the canister on the ATC, scans the ATC barcode, and scans thesecurity tag (i.e., cable tie) barcode 214. The line control applicationreceives the barcode data, performs a look up on the barcode data 216,and confirms the pharmacist-verified canister has been loaded on theappropriate ATC 218.

Once verified by a pharmacist, a change to the contents of a canisterrequires a breach of container, whether accidental or unintentional. Aslong as the pharmacist-verified canister remains intact during transportto the dispensing line and is loaded on the correct ATC, the ATCdispenses the appropriate drug. After an ATC has been replenished, thetablets or pills are automatically dispensed into vials and the vialsare routed on the dispensing line for packaging. Filled vialsautomatically drop into labeled packages that are then sealed. As aresult, in normal operation, no human contact or intervention with vialsoccurs after they have been filled from pharmacist-verified canisters.

In addition to verifying the contents of ATC replenishment canisters,pharmacists verify a specified percentage of orders for each ATC. In anexample embodiment, a series of orders (e.g., specified number of ordersfollowing replenishment) are selected for pharmacist verification.Additionally, orders may be selected at random for pharmacistverification to ensure an appropriate number of orders are verified tomeet verification requirements. For every ATC, a “Send to PV Frequency”parameter is configured. The parameter is based on the percentage oforders that are verified to meet state regulations or guidelines such asrequirements from a state Board of Pharmacy.

Pharmacist verification is performed by capturing and displaying at aworkstation the verification data that the pharmacist needs to reviewand verify a prescription order. The verification data includesprescribed drug data from the order (e.g., drug name, strength, dosageform, and quantity prescribed) and a digital image of a drug dispensedinto a vial for shipment to the patient. The digital images are acquiredfrom digital camera systems that are integrated into the automateddispensing line. During the fulfillment process, a digital image ofevery filled vial is captured and stored with the order data. Thepharmacist reviews the prescription order data and image of the vialcontents shown at the workstation to confirm the proper drug has beenadded to the vial to be dispensed to the patient.

Referring to FIG. 5, a flowchart of a pharmacist verification softwaremodule according to an example embodiment is shown. The pharmacistreceives the verification requests 230 and displays the order data andvial image 232. The pharmacist completes the review and submits an orderacceptance indicator 234. The order approval status is transmitted tothe line control application 236. If the order is approved 238, the vialis routed for shipment to the patient 240. If the order is not approved238, the vial is routed for exception handling 242.

Vials that are not subject to pharmacist verification are“auto-verified” by the line control application. When a puck isauto-verified, the line control application determines the pharmacistidentifier that performed the canister replenishment verification forthe Active NDC, Active Lot Number, and Active Canister Identifier. Thepharmacist identifier is then associated with the puck/vial andtherefore, the order data. The item is also flagged as “auto-verified”in the system database. When a drug is dispensed from an ATC into a vialsuccessfully, the line control application marks the puck/vial asverified unless one of the following conditions is met:

TABLE 1 Auto-Verify Failure Conditions Sensor mismatch or allowableover/under count Puck/vial routed to PV station; pharmacist verifiesoccurred. quantity. Randomly generated number for order falls withinPuck/vial routed to PV station. configured “Send to PV Frequency” forATC. Puck is one of first “Number of Pucks to PV After Puck/vial routedto PV station. System flags Replenishment” system parameter after singleorders or puck/vials already flagged to go replenishment of ATC. (e.g.,if 1,000 pills are left to a tote line for PV (less invasive to the inthe old canister when replenishment occurred, depucker). If a “Max ATCPV Skips” number of then after those 1,000 pills are dispensed, requirepuck/vials do not qualify according to this logic manual pharmacistverification of the next N (i.e., requisite number of puck/vials havenot pucks/vials to dispense from that ATC. been routed to manual PV),send the next puck/vials to manual PV regardless of their nature untilthe requisite number of pucks have been sent. Order includes a “manualpick puck” item. Puck is routed to a separate “tote line” for PV. When apuck is flagged for tote line PV, all pucks in that order are flaggedfor routing to the tote line; pharmacist verifies only vials that werenot auto-verified.

Vials that are auto-verified are also imaged during the dispensingprocess so that an image of the vial contents can be archived with theorder. If the need arises after the order has been filled, the vialcontents can be verified using the order data and archived image.

The disclosed pharmaceutical order verification system and methodcomprises a computerized line control application that operates inconjunction with security and control procedures to maximize thelikelihood the correct drug is dispensed from an ATC. Pharmacistverification occurs in connection with replenishing the drugs in ATCsand in connection with verifying a specified percentage of orders foreach ATC. Each verification step is supported by computerized technologyto collect and record data during the verification step. While certainembodiments of the present invention are described in detail above, thescope of the invention is not to be considered limited by suchdisclosure, and modifications are possible without departing from thespirit of the invention as evidenced by the following claims:

1. A computerized method for processing vials on an automated dispensingline comprising: (a) assigning at a server to an automated tabletcounter (ATC) identifier: (1) an ATC barcode; and (2) drug identifyingdata for a drug dispensed from said ATC; (b) assigning at said server toa drug canister identifier a drug canister barcode; (c) assigning atsaid server to a canister security tag a security tag barcode; (d)receiving at said server a replenishment request comprising said ATCidentifier; (e) receiving at said server a pharmacist verificationapproval for said replenishment request confirming contents of said drugcanister matches said drug identifying data; (f) receiving at saidserver barcode scan data for a scanned ATC, a scanned drug canister, anda scanned security tag; (g) confirming at said server said barcode scandata matches said ATC barcode, said drug canister barcode, and saidsecurity tag barcode; (h) receiving at said server filled prescriptionorder data for a plurality of vials filled at said ATC; and (i)receiving at said server pharmacist verification order approval statusfor a specified number of said plurality of vials.
 2. The computerizedmethod of claim 1 wherein said drug identifying data comprises a drugcode, a drug strength, and a drug dosage.
 3. The computerized method ofclaim 1 wherein said security tag barcode is a barcode for a cable tie.4. The computerized method of claim 1 wherein said specified number ofsaid plurality of vials is a percentage of said plurality of vials. 5.The computerized method of claim 1 wherein said specified number of saidplurality of vials is a specified number of vials followingreplenishment.
 6. The computerized method of claim 1 wherein saidreplenishment request comprises said ATC identifier and an ATC locationon a dispensing line.
 7. The computerized method of claim 1 furthercomprising: (j) routing said specified number of said plurality of vialsaccording to said order approval status.
 8. The computerized method ofclaim 7 further comprising: (k) if said order approval status isapproved, routing said vial for shipment; and (l) if said order approvalstatus is not approved, routing said vial for exception handling.
 9. Acomputerized system for processing vials on an automated dispensing linecomprising: (a) a server executing programming instructions to: (1)assign at said server to an automated tablet counter (ATC) identifier:(i) an ATC barcode; and (ii) drug identifying data for a drug dispensedfrom said ATC; (2) assign at said server to a drug canister identifier adrug canister barcode; (3) assign at said server to a canister securitytag a security tag barcode; (4) receive at said server a replenishmentrequest comprising said ATC identifier; (5) receive at said server apharmacist verification approval for said replenishment requestconfirming contents of said drug canister matches said drug identifyingdata; (6) receive at said server barcode scan data for a scanned ATC, ascanned drug canister, and a scanned security tag; (7) confirm at saidserver said barcode scan data matches said ATC barcode, said drugcanister barcode, and said security tag barcode; (8) receive at saidserver filled prescription order data for a plurality of vials filled atsaid ATC; (9) receive at said server pharmacist verification orderapproval status for a specified number of said plurality of vials; and(b) a pharmacist verification station executing programming instructionsto: (1) display a replenishment confirmation request for said drugcanister; (2) receive and transmit to said server said pharmacistverification approval for said replenishment request confirming contentsof said drug canister matches said drug identifying data; (3) displaypharmacist verification approval requests for said specified number ofsaid plurality of vials; and (4) receive and transmit to said serverpharmacist verification order approval status for said specified numberof said plurality of vials.
 10. The computerized system of claim 9wherein said drug identifying data comprises a drug code, a drugstrength, and a drug dosage.
 11. The computerized system of claim 9wherein said security tag barcode is a barcode for a cable tie.
 12. Thecomputerized system of claim 9 wherein said specified number of saidplurality of vials is a percentage of said plurality of vials.
 13. Thecomputerized system of claim 9 wherein said specified number of saidplurality of vials is a specified number of vials followingreplenishment.
 14. The computerized system of claim 9 wherein saidreplenishment request comprises said ATC identifier and an ATC locationon a dispensing line.
 15. The computerized system of claim 9 whereinsaid server further executes programming instructions to: (10) routesaid vial for shipment if said order approval status is approved; and(11) route said vial for exception handling if said order approvalstatus is not approved.
 16. A computerized method for processing vialson an automated dispensing line comprising: (a) receiving at a server averify message for a dispensing operation of a drug from an automatedtablet counter (ATC) to a vial, said verify message comprising: (1) anATC identifier; and (2) a success indicator indicating said drugdispensed successfully; (b) assigning by said server to a drug order forsaid drug: (1) an auto-verify indicator indicating said drug dispensedsuccessfully; and (2) a pharmacist identifier for a pharmacistperforming a replenishment operation for said ATC.
 17. The computerizedmethod of claim 16 further comprising: (c) capturing an image of saidvial with said drug; and (d) storing said image with said drug order.18. The computerized method of claim 16 further comprising: (c)receiving at said server a second verify message for a second dispensingoperation of said drug from said automated tablet counter (ATC) to asecond vial, said verify message comprising: (1) said ATC identifier;and (2) a failure indicator indicating said drug did not successfullyverify.
 19. The computerized method of claim 16 further comprising: (c)checking by said server said drug order for pharmacist verification; and(d) routing by said server said vial for pharmacist verification. 20.The computerized method of claim 19 wherein checking by said server saiddrug order for pharmacist verification comprises using a randomlygenerated number for said drug order to route said vial for pharmacistverification.